Medical Devices

Unique Device Identification - UDI

 

FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public will be able to search and download information from the GUDID.

The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.

If you have a question or concern you’d like to share with the UDI team, please contact the FDA UDI Help Desk.